IVD & Biomarker Assay Feasibility
Define intended use and evidence gaps before choosing a biomarker assay or validation panel. Research feasibility is not clinical diagnostic authorization.
Start with the claim, not a universal panel
Explain what is measured, in which specimen, for whom and how a result would be used. Research-use-only work and clinical IVD claims need different evidence strategies. An RUO label does not authorize clinical diagnostic use. Neither a feasibility result nor analytical validation automatically establishes clearance or clinical benefit.
Analytical versus clinical performance
Analytical performance addresses measurement behavior; clinical sensitivity and specificity address classification against a justified clinical reference in an intended population. Where no suitable reference exists, agreement measures need careful interpretation and must not be renamed clinical sensitivity/specificity. Qualified clinical-study teams should determine design, recruitment, ethics, consent, specimen access and applicable oversight before any clinical work.
Product-specific evidence
FDA guidance for influenza diagnostics illustrates specimen, analytical and clinical study considerations for that product category only. It is not a mandatory template for unrelated biomarkers. Identify the actual intended-use category and current FDA resources with qualified regulatory specialists; an unnamed biomarker cannot be assigned a universal test package.
What to include in your request
Start with the intended decision and available evidence.
- Intended use, research-only versus clinical purpose, biomarker/analyte and decision to support; disclose confidential identities only in private follow-up.
- Assay format, instrument/software versions, qualitative/quantitative output, specimen matrix, collection container, handling and storage conditions.
- Available reference materials, reagent/calibrator lots, candidate/comparator method, target range or decision threshold and existing evidence.
- Proposed claims, report and study design, sample availability, ethics/consent requirements, budget, location and milestones; ask the provider to propose justified methods.
Laboratories with relevant capabilities
No directory profile currently documents this specific capability. Submit a request and we will look for laboratories that cover it.
Sources and scope references
FDA — IVD labeling and performance information
FDA — influenza IVD performance guidance (product-specific example, not universal)
Related testing briefs
B2B molecular assay development
Confirm standard edition, jurisdiction and actual laboratory scope. Service references are not partnerships or endorsements.